FDA 510(k)

코반 fecalSwab 수집, 운송 및 보존 시스템

K-번호: K220052 · 2022-12-16

결정일2022-12-16

제품 코드JSM

자문 위원회미 (Original text: MI)

결정대체적으로 동일

기기 요약

Copan FecalSwab Collection, Transport and Preservation System is the device name listed in this FDA 510(k) record. The listed applicant is Copan Italia Spa. It received FDA 510(k) clearance on 2022-12-16 under 510(k) number K220052. The device is classified under product code JSM. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the Copan FecalSwab Collection, Transport and Preservation System?

Copan FecalSwab Collection, Transport and Preservation System is a medical device that received FDA 510(k) clearance on 2022-12-16. The listed applicant is Copan Italia Spa. The 510(k) number is K220052.

When did Copan FecalSwab Collection, Transport and Preservation System receive FDA 510(k) clearance?

Copan FecalSwab Collection, Transport and Preservation System received FDA 510(k) clearance on 2022-12-16, under 510(k) number K220052.

Who is the listed applicant for Copan FecalSwab Collection, Transport and Preservation System?

The FDA 510(k) record lists Copan Italia Spa as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Copan FecalSwab Collection, Transport and Preservation System?

The FDA product code for Copan FecalSwab Collection, Transport and Preservation System is JSM.

Copan Italia Spa를 신청인으로 등재한 기타 기록

K232565UriSponge™K232357코반 유니버설 트랜스포트 미디어 (UTM-RT) 시스템 K201849eNAT 분자 수집 및 보존 용액 K180052UriSwab-尿液収集, 运送 및 보존 시스템

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